A Dutch radio programme has raised further concerns about the role of unpublished, industry sponsored medical research on the risks of taking the third generation of contraceptive pill.
In its second broadcast in two months on the subject, the investigative programme Argos stated that a new study had been carried out but its results had not yet been published. The study, requested by the European Medicines Evaluation Agency, was carried out by several manufacturers of contraceptive pills, with the company Organon Netherlands acting as the "coordinating sponsor."
The agency confirmed to the programme makers that the study was complete and that the manufacturers were free to publish the results, but the agency could not release the results under its own procedures.
Dutch radio put the study's outline protocols, published in Contraception (1999;59:345-55), to Professor Mike Greaves, senior editor of the British Journal of Haematology , for a comment.
Professor Greaves was concerned that the research data were available only through the sponsoring company. The design of the so-called "open label" study was "not ideal if you want unbiased results." He argued that a "fundamental requirement" would be "independent scrutiny by knowledgeable peers."
In March the same Dutch radio programme, Argos, stated that the pill manufacturer Wyeth-Ayerst had undertaken research in 1997, which remained unpublished, although it showed an increased risk of developing deep vein thrombosis, in several third generation contraceptive pills (BMJ 2001,322:571).
Wyeth-Ayerst claimed that the report "did not add anything" to existing knowledge of the subject and that the study design was flawed, but they had submitted the results to the European Medicines Evaluation Agency.
Observers have highlighted concerns over a discrepancy in the 16 major studies into the safety of the third generation pill since the World Health Organization raised concerns in 1995. The 12 independent studies found evidence of increased risks, while the four industry sponsored studies did not. If the study by Wyeth-Ayerst had been published, it would have been the first by the industry to have shown an increased risk.
Willem de Laat, medical director of Organon Netherlands, defended the latest study, saying that the agency had asked them to conduct it, the companies had paid for it, the protocol was not secret, and the study had been overseen by an independent scientific advisory board. It was the company's intention to publish it in a scientific journal within six months.
He said: "It is scientifically disappointing that nobody asks what could be the cause of the difference [between the second and third generation contraceptive pills] but instead implies that there is something suspicious about company sponsored research."
The BMJ had been invited to take part in the programmes as it has recently published both independent and industry sponsored studies, later accepting criticism of the industry study (BMJ 2000;321:1171-2).
This led Organon to claim in the programme that the BMJ had judged the two studies differently. Dr Richard Smith, editor of the BMJ , told Dutch radio: "I don't accept at all that we were biased. I do accept the papers were handled differently, and that is a matter of public record."
The agency is currently evaluating all research on the issue. Last week its Committee for Proprietary Medicinal Products heard evidence from the three main pill manufacturers, Organon Netherlands, Wyeth-Ayerst, and Schering. Dutch parliamentary answers have shown that advice from the committee to the public, expected last year, is now due at the end of June. A provisional standpoint by the committee was disputed by the pill manufacturers in January.
